Sinuses are hollow spaces within the facial bones which are lined with delicate membranes called mucosa, as are the nasal passages, which run from the nostrils to the pharynx. Sinusitis is an inflammation of the mucosa of the sinuses, which can be caused by allergies or infection by viruses, fungi, or bacteria. Rhinitis is inflammation of the mucosa of the nasal passages, and can also have one or more causes. These conditions often occur together as rhinosinusitis.
Symptoms of sinusitis are typically more severe than symptoms of rhinitis. Each of these conditions may be categorized as acute or chronic depending on the duration of the symptoms. Symptoms may include nasal congestion, runny or stuffy nose, white, yellow or green discharge, headache, night time cough, pain in the upper jaw or teeth, fatigue, and fever. More serious infections such as ear infections or meningitis may sometimes follow.
Multiple approaches to treating sinusitis exist, including surgery. Irrigation of the operated or non-operated nasal passages and sinus cavities with a nasal rinse can reduce the symptoms of sinusitis. Nasal rinsing typically uses a saline solution which is dispensed into the nasal passage to clear away allergens, irritants and mucus. This facilitates normal drainage of the sinuses, disrupts microbial growth, and reduces inflammation. Such nasal irrigations with saline solutions have been known and used for years.
Nasal irrigation dispensers for use with saline solutions have been described, as for example in U.S. Pat. No. 5,806,723 (“Device for Lavaging”) and U.S. Pat. No. 3,847,145 (“Nasal Irrigation System”), the contents of each of which are hereby incorporated in their entirety. Other disclosed techniques or devices include U.S. Pat. No. 6,520,384 (“Apparatus and method for nasal rinse”), U.S. Pat. No. 6,669,059 (“System and method for passage rinse”), and U.S. Pat. No. 6,540,718 (‘Appliance for rinsing”), the contents of each of which are hereby incorporated in their entirety.
A common treatment for sinusitis is the use of antibiotics (antibacterials, antimicrobials), administered orally or intravenously. However, topical application of antibiotics can provide higher concentrations of the drug at the site of the infected sinuses. Topical application can also achieve lower systemic exposure to the antibiotic, potentially reducing side effects associated with a particular agent. The use of nasal nebulizers to provide aerosolized antibiotic agents to the nasal passages has been described, as in U.S. Pat. No. 6,576,224 (“Aerosolized Anti-Infectives, Anti-inflammatories, and Decongestants for the Treatment of Sinusitis”), the contents of which are hereby incorporated in their entirety. Inhalation treatments, however, can be problematic so far as achieving sufficient levels of medicament in the site of infected sinuses.
Nasal irrigation methods using nasal irrigation fluids comprising antibiotic agents, including antibiotic agents, can provide good exposure of the medicament in the infected sinuses while minimizing the irritant effects sometimes associated with aerosolized sprays.
Shapiro et al., WO 2011/094504, describe the topical administration of antibiotic formulations by nasal irrigation. Banov, U.S. Patent Publication No. US 2014/0371305, discloses an antibiotic irrigation composition for the treatment of bacterial infection in the respiratory tract, comprising the antibiotic mupirocin. The contents of these two publications are hereby incorporated into the present application in their entireties.
There remains a need for new nasal irrigation compositions of antibiotic agents that can deliver medicaments in therapeutic concentrations.